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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025439
Receipt No. R000029253
Scientific Title The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy.
Date of disclosure of the study information 2016/12/27
Last modified on 2016/12/27

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Basic information
Public title The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy.
Acronym The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy.
Scientific Title The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy.
Scientific Title:Acronym The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy.
Region
Japan

Condition
Condition tonsil hypertrophy
IgA nephropathy
chronic tonsillitis
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the effectiveness of Kikyo-To
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NRS
Key secondary outcomes CRP

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 take Kikyo-to 7.5g/day.
Interventions/Control_2 take Kikyo-to for 2days after operation.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria ASA1-2
Key exclusion criteria ASA>3
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Maeda
Organization Juntendo Univ. Urayasu Hospital
Division name department of Anethesiology
Zip code
Address 2-1-1 Tomioka,Urayasu-shi,Chiba,Japan
TEL 047-353-3111
Email ichinimaeda@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Maeda
Organization Juntendo Univ. Urayasu Hospital
Division name department of Anethesiology
Zip code
Address 2-1-1 Tomioka,Urayasu-shi,Chiba,Japan
TEL 047-353-3111
Homepage URL
Email ichinimaeda@gmail.com

Sponsor
Institute Juntendo Univ.
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 27 Day
Last modified on
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029253

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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